ChiCTR2200066688 版本V1.2 版本创建时间2023/09/13 21:04:23 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200066688 

最近更新日期：

Date of Last Refreshed on：

 2023-09-12 23:23:35 

注册时间：

Date of Registration：

 2022-12-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

注册用甲磺酸齐拉西酮的人体生物等效性预实验

Public title：

Pre-experiment of human bioequivalence of ziprasidone mesylate for registration

注册题目简写：

English Acronym：

研究课题的正式科学名称：

注册用甲磺酸齐拉西酮的人体生物等效性预实验

Scientific title：

Pre-experiment of human bioequivalence of ziprasidone mesylate for registration

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

严新 

研究负责人：

阳国平 

Applicant：

Xin Yan 

Study leader：

Guoping Yang 

申请注册联系人电话：

Applicant telephone：

 +86 138 7017 3936

研究负责人电话：

Study leader's
telephone：

+86 731 8991 8665

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 yx13870173936@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzibo Road, Yuelu District, Changsha, Hunan

Study leader's address：

138 Tongzibo Road, Yuelu District, Changsha, Hunan

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 22111

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中南大学湘雅三医院伦理委员会医学伦理分委员会

Name of the ethic committee：

The IRB of the Third Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-09-21 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin WANG

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 88618938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院临床试验中心

Primary sponsor：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan Province

City：

Changsha City

单位(医院)：

中南大学湘雅三医院临床试验中心

具体地址：

湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

Address：

138 Tongzibo Road, Yuelu District, Changsha City, Hunan Province

经费或物资来源：

南京正大天晴制药有限公司

Source(s) of funding：

Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.

研究疾病：

激越  

Target disease：

agitation

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要目的：以南京正大天晴制药有限公司研制、生产的注射用甲磺酸齐拉西酮（30 mg/瓶）为受试制剂，Pfizer Inc 持证、Pharmacia and Upjohn Company LLC 公司生产的注射用甲磺酸齐拉西酮（30 mg/瓶，Geodon?）为参比制剂，研究受试制剂和参比制剂在健康志愿者空腹状态下单次肌肉注射给药时的药代动力学特征，初步评价两制剂的人体生物等效性。 次要目的：观察健康志愿者单次肌肉注射受试制剂和参比制剂的安全性。  

Objectives of Study：

The main objective: to study the pharmacokinetic properties of the test formulation and the reference formulation of ziprasidone mesylate for injection (30 mg/vial) developed and manufactured by Nanjing Zhengda Tianqing Pharmaceutical Co. The pharmacokinetic characteristics of the test formulation and the reference formulation were investigated during single intramuscular administration in healthy volunteers under fasting conditions, and the human bioequivalence of the two formulations was preliminarily evaluated. Secondary objective: To observe the safety of the test formulation and the reference formulation during a single intramuscular injection in healthy volunteers.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

志愿者必须符合下列所有标准才能入选：
1) 年龄在 18~45 周岁（含临界值）的中国志愿者，男女均可；
2) 男性志愿者的体重≥50.0 kg，女性志愿者的体重≥45.0 kg，体重指数（BMI）在 19 ~26 kg/m2之间，含临界值；
3) 志愿者自愿签署书面的知情同意书。

Inclusion criteria

To be selected, volunteers must meet all of the following criteria.
1) Chinese volunteers aged 18 ~ 45 years (including the threshold), both sexes.
2) Male volunteers weighing ≥50.0 kg and female volunteers weighing ≥45.0 kg with a body mass index (BMI) between 19 ~26 kg/m2, including the threshold.
3) Volunteers voluntarily signed a written informed consent form.

排除标准：

符合一条或多条下列标准的志愿者将被排除：
1) 既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病者或能干扰试验结果的任何其他疾病，如既往有肿瘤病史者、既往有心血管疾病史（如高血压、心动过缓、心动过速、心律失
常、QT 间期延长、心肌梗死、心力衰竭等）者；
2) 首次用药前 7 天内出现恶心、头晕、头痛、嗜睡等症状，且研究者认为不宜参加试验者；
3) 试验前 4 周内接受过外科手术，或计划在研究期间进行外科手术者；
4) 有药物、食物或其他物质过敏史；对本品及辅料中任何成份过敏，或对同类药物有过敏史者，或有过敏性疾病史（如过敏性皮炎、血管神经性水肿、口面部水肿、荨麻疹等）且研究者认为目前仍有临床意义者；
5) 试验前 30 天内使用过任何在药效学方面具有延长 QT 间期作用的药物、或在处方信息中禁忌用于QTc间期延长患者的药物、或有黑框警告慎重用于QTc间期延长患者的药物者；
6) 试验前 14 天内使用过任何药物者（包括维生素及中草药）；
7) 试验前 3 个月内服用了任何临床试验药物或参加了任何药物临床试验者；
8) 试验前 3 个月内献血或失血大于 200 mL 者，或计划在研究期间或研究结束后三个月内献
血或血液成分者；
9) 志愿者（或其伴侣）试验期间至试验结束后 3 个月内有妊娠计划、捐精捐卵计划，或试验期间不能采用一种或一种以上的非药物避孕措施（如完全禁欲、避孕环、伴侣结扎等）者；
10) 妊娠或哺乳期女性，或女性志愿者妊娠检查结果阳性者；
11) 对饮食有特殊要求，不能遵守统一饮食者；
12) 嗜烟者或试验前 3 个月每日吸烟量多于 5 支者，或试验期间不能停止使用任何烟草类产品者；
13) 酗酒者或试验前 6 个月内经常饮酒者，即每周饮酒超过 14 单位酒精（1 单位=360 mL 啤酒或 45 mL 酒精量为 40%的烈酒或 150 mL 葡萄酒），或试验期间不能停止使用任何含酒精产品者；
14) 每天饮用过量茶、咖啡和/或含咖啡因的饮料（8 杯以上，1 杯=250 mL）者；
15) 药物滥用者或者试验前 3 个月使用过软毒品（如：大麻）或试验前 1 年服用硬毒品（如：可卡因、苯环己哌啶等）者；
16) 不能耐受静脉穿剌或有晕血、晕针史者；
17) 预计静脉穿刺或采血困难者；
18) 筛选期生命体征异常者（收缩压<90 mmHg 或>140 mmHg，舒张压<60 mmHg 或>90 mmHg；脉搏<50 bpm 或>100 bpm）或体格检查、心电图、实验室检查异常有临床意义者（以临床医师判断为准）；
19) 首次用药前 48 小时内，摄入任何含有咖啡因、酒精、黄嘌呤或葡萄柚成分等的食物或饮料（如咖啡、浓茶、巧克力等）者；
20) 筛选时 QT 延长或男性 QTc 间期≥450ms、女性 QTc 间≥470ms 者；
21) 筛选时肌酐清除率＜80 mL/min 者；
22) 酒精呼气检测异常（>0 mg/100 mL）者；
23) 药物滥用筛查（吗啡、甲基安非他明、氯胺酮、四氢大麻酚酸、亚甲二氧基甲基安非他明）试验阳性者；
24) 从事危险的机械操作（例如驾驶汽车或重型机械）、高空作业等工作，且研究者认为不宜参加试验者；
25) 志愿者可能因为其他原因而不能完成本研究或研究者认为不应纳入者。

Exclusion criteria：

Volunteers who meet one or more of the following criteria will be excluded.
1) Those with any previous or current clinically serious diseases of the circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric and metabolic abnormalities or any other diseases that can interfere with the test results, such as those with a previous history of oncology, previous history of cardiovascular disease (e.g. hypertension, bradycardia, tachycardia, arrhythmia
(e.g., hypertension, bradycardia, tachycardia, arrhythmia, prolonged QT interval, myocardial infarction, heart failure, etc.).
2) those who have experienced nausea, dizziness, headache, drowsiness, etc. within 7 days prior to the first dose and who are considered by the investigator to be unfit to participate in the trial.
3) those who have undergone surgical procedures within 4 weeks prior to the trial or are scheduled to undergo surgical procedures during the study
4) those who have a history of allergy to drugs, food or other substances; those who are allergic to any of the components of the product and excipients, or have a history of allergic disease (e.g., atopic dermatitis, angioneurotic edema, orofacial edema, urticaria, etc.) and who, in the opinion of the investigator, are still clinically significant
5) Those who have used any drug within 30 days prior to the trial that has a pharmacodynamic effect in prolonging the QT interval, or that is contraindicated in the prescribing information for use in patients with prolonged QTc interval, or that has a black box warning caution for use in patients with prolonged QTc interval
6) those who have used any medication (including vitamins and herbal medicines) within 14 days prior to the trial
7) those who have taken any clinical trial drug or participated in a clinical trial of any drug within 3 months prior to the trial
8) Donated blood or lost more than 200 mL of blood within 3 months prior to the trial, or plan to donate blood or blood components during the study or within 3 months after the study.
8) Those who have donated blood or blood components within 3 months prior to the trial, or those who plan to donate blood or blood components during the study or within 3 months after the study.
9) Volunteers (or their partners) who are planning to become pregnant during the trial until 3 months after the end of the trial, who are planning to donate sperm and eggs, or who are unable to use one or more non-pharmaceutical contraceptive measures (e.g., total abstinence, IUD, partner ligation, etc.) during the trial
10) Pregnant or lactating females, or female volunteers with positive pregnancy test results
11) Those with special dietary requirements who cannot comply with a uniform diet
12) smokers or smokers who smoked more than 5 cigarettes per day in the 3 months before the trial, or who could not stop using any tobacco products during the trial or who cannot stop using any tobacco products during the trial.
13) Alcoholics or regular drinkers in the 6 months prior to the trial, i.e., those who consume more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol) or 45 mL of 40% alcoholic spirits or 150 mL of wine) per week, or who cannot stop using any product containing alcohol during the trial. alcoholic products during the test.
14) Persons who consume excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day
15) Substance abusers or those who have used soft drugs (e.g., marijuana) in the 3 months prior to the trial or hard drugs (e.g., cocaine, phencyclidine, etc.) in the year prior to the trial
16) Those who cannot tolerate venipuncture or have a history of blood or needle sickness
17) Those with anticipated difficulties with venipuncture or blood collection
18) those with abnormal vital signs during the screening period (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <60 mmHg or >90 mmHg; pulse <50 bpm or >100 bpm) or those with clinically significant abnormalities on physical examination, electrocardiogram, or laboratory tests (as judged by the clinician)
19) Those who have ingested any food or beverage containing caffeine, alcohol, xanthine or grapefruit components, etc. (e.g. coffee, strong tea, chocolate, etc.) within 48 hours prior to the first dose
20) those with prolonged QT or QTc interval ≥ 450ms in men and ≥ 470ms in women at screening
21) creatinine clearance <80 mL/min at the time of screening.
22) those with abnormal alcohol breath test (>0 mg/100 mL)
23) positive drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid, methylenedioxymethamphetamine ) test positive.
24) Those who are engaged in hazardous mechanical operations (e.g., driving a car or heavy machinery), work at heights, etc., and who, in the opinion of the investigator, are not who are considered by the investigator to be unfit to participate in the test.
25) Volunteers who may not be able to complete the study for other reasons or who, in the opinion of the investigator, should not be included.

研究实施时间：

Study execute time：

从 From 2022-12-15 00:00:00至 To 2023-12-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-16 00:00:00 至 To 2023-12-15 00:00:00

干预措施：

Interventions：

组别：

T-R

样本量：

 6

Group：

test preparation-reference preparation

Sample size：

干预措施：

第一周期受试制剂T,第二周期参比制剂R

干预措施代码：

Intervention：

First cycle test preparation T, second cycle reference preparation R

Intervention code：

组别：

R-T

样本量：

 6

Group：

reference preparation-test preparation

Sample size：

干预措施：

第一周期参比制剂R受试制剂T,第二周期受试制剂T

干预措施代码：

Intervention：

First cycle reference preparation Rest preparation T, second cycle test preparation T

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China

Province：

Hunan Province

City：

Changsha City

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

the Third Xiangya Hospital of Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血浆浓度

指标类型：

主要指标

Outcome：

Plasma concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

Physical examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检查

指标类型：

次要指标

Outcome：

laboratory teat

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应

指标类型：

主要指标

Outcome：

Adverse reactions

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

严重不良事件

指标类型：

主要指标

Outcome：

Serious Adverse Events

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

十二导联心电图

指标类型：

主要指标

Outcome：

Twelve-lead electrocardiogram

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 45 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

在研究中每名志愿者接受受试制剂或参比制剂的顺序将由随机表确定。随机表由统计单位应用 SAS（9.4 或更高版本）按区组随机产生，组间比例为 1:1。在筛选时，每名志愿者将使用筛选号进行识别。筛选号以“S”为前缀，以志愿者筛选的前后顺序为后缀（如S001、S002、S003 等）。 试验的第-1 天进行随机。按照筛选号从小到大，每名合格的志愿者将获得一个随机号。每名合格的志愿者将按照筛选号从小到大获得随机号（如 Y001、Y002…….Y012）。试验每周期给药一次，健康志愿者随机分配至 T-R 序列或 R-T 序列，各 6 人，志愿者每周期按照随机表空腹状态下肌肉注射对应的试验药物。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The order in which each volunteer receives the test or reference formulation in the study will be determined by a randomization table generated by the statistical unit using SAS (version 9.4 or higher) in a 1:1 ratio between groups. The randomization table will be generated by the statistical unit using

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本次临床研究为开放性研究，除生物样本检测人员外，对其他临床试验人员不设盲。在数据统计分析前，生物样本检测分析人员将不获得志愿者分组信息及随机给药信息，以消除样本测试过程中可能存在的偏移。

Blinding：

This clinical study is an open study and is not blinded to clinical trial personnel other than the biospecimen testing personnel. Prior to statistical analysis of the data, the biospecimen testing analysts will not be provided with volunteer grouping information and random drug administration information in order to eliminate possible bias during sample testing.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

文章发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Article Publication

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用纸质 CRF：本次试验采用纸质 CRF 采集数据。 1.纸质 CRF 对应的数据管理大致流程：CRC 填写纸质 CRF（pCRF）；监查员进行现场核查（SDV）；数据疑问和解答：研究者根据疑问进行解答并在答疑表中签字确认。该过程如此反复，直到疑问被全部解决，数据清洁。 2.医学编码：不良事件采用 MedDRA V22.0 或更高版本字典进行编码，合并用药采用 WHO ATC进行分类。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Use of paper CRF: This trial used paper CRF to collect data. 1. Paper CRF corresponds to the general process of data management: CRC fills in the paper CRF (pCRF); the supervisor performs the site verification (SDV); data queries and answers: the investigator answers the queries according to the queries and signs the answer form to confirm. The process is repeated until the queries are all resolved and the data are clean. 2. Medical coding: Adverse events were coded using MedDRA V22.0 or higher dictionary, and combined medications were classified using WHO ATC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

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  2022-12-13 19:57:15